Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension

Fayoum University

Status and phase: Completed; Early Phase 1

Conditions: Idiopathic Intracranial Hypertension

Treatments: Drug: acetazolamide; Drug: LMWH

Study type: Interventional

Funder types: Other

Identifiers

NCT03963336

M201

Details and patient eligibility

About

Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology.

The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients.

Full description

24 patients with IIH according to the modified Dandy criteria were enrolled. Headache impact test (HIT6), ophthalmological assessment including Frisen classification for papilledema, visual acuity, visual field by perimetry, and visual evoked potentials were performed to the patients.

Serum quantitative D-dimer level was measured using the enzyme-linked immunosorbent assay (ELISA) technique for the patients and for 24 healthy matched controls.

Patients were divided into two groups: group (A) received acetazolamide and low molecular weight heparin (LMWH) in a prophylactic dose for 2 weeks while group (B) received acetazolamide only. Both groups continued the acetazolamide 1-2g/day for 6 months.

The investigators followed-up the patients after one and six months later through the HIT6 test and the ophthalmological assessment.

Enrollment: 48 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• IIH patients of both sexes fulfilling the modified Dandy criteria

Exclusion criteria

• disturbed conscious level, focal neurological signs, seizures, cerebral venous sinus thrombosis or stenosis, deep venous thrombosis or pulmonary embolism, malignancy, and acute nephritic syndrome.
• Patients with signs of disseminated intravascular coagulopathy and septic sinus thrombosis
• patients with a history of cerebral granuloma or infection, cerebrovascular stroke, head trauma or surgery.
• pregnant females or those who terminated their pregnancy in the last four weeks were also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Group A

Active Comparator group

Description:

12 IIH patients for whom serum D-dimer was assessed by ELISA.They received acetazolamide and anticoagulant LMWH in the prophylactic dose for 2 weeks then continued on acetazolamide. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials)

Treatment:

Drug: LMWH

Drug: acetazolamide

Group B

Active Comparator group

Description:

12 IIH patients for whom serum D-dimer was assessed by ELISA. They received acetazolamide only. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials)

Treatment:

Drug: acetazolamide

Control group

No Intervention group

Description:

24 healthy subjects for whom serum D-dimer was assessed by ELISA.